2026 年第 4 期 第 21 卷

生脉强心颗粒调控肾素-血管紧张素-醛固酮系统改善老年慢性心力衰竭的临床疗效观察

Clinical efficacy observation of Shengmai Qiangxin granules in improving senile chronic heart failure by regulating the renin-angiotensin-aldosterone system

作者：徐倩1万冬梅1邓立梅1高媛1田淇元2

英文作者：Xu Qian1 Wan Dongmei1 Deng Limei1 Gao Yuan1 Tian Qiyuan2

单位：1黑龙江中医药大学附属第二医院心病二科，哈尔滨150001；2黑龙江中医药大学附属第一医院心血管病一科，哈尔滨150040

英文单位：1Second Department of Heart Second Affiliated Hospital Heilongjiang University of Chinese Medicine Harbin 150001 China; 2First Department of Cardiovascular First Affiliated Hospital Heilongjiang University of Chinese Medicine Harbin 150040 China

关键词：慢性心力衰竭；肾素-血管紧张素-醛固酮系统；生脉强心颗粒

英文关键词：Chronicheartfailure;Renin-angiotensin-aldosteronesystem;ShengmaiQiangxingranules

• 摘要：

• 目的 探讨生脉强心颗粒治疗老年慢性心力衰竭（CHF）的临床效果及对肾素-血管紧张素-醛固酮系统（RAAS）的调控作用。方法 采用前瞻性随机对照试验设计，选取2022年1月至2025年1月黑龙江中医药大学附属第二医院收治的94例气阴两虚夹瘀型老年CHF患者，采用分层区组随机化方法 分为对照组和观察组，各47例。对照组接受常规西药和中药安慰剂治疗，观察组在常规西药治疗基础上加用生脉强心颗粒治疗，疗程8周。比较2组疗效、中医证候积分、6 min步行试验距离、生活质量、心功能指标、N末端B型脑钠肽前体（NT-proBNP）、肌钙蛋白I（TnI）、肌酸激酶同工酶（CK-MB）以及RAAS指标血清肾素活性（PRA）、血管紧张素Ⅱ（AngⅡ）、醛固酮水平。比较2组不良反应发生情况。结果 观察组治疗后总有效率高于对照组［93.6%（44/47）比74.5%（35/47）］（P=0.011）。2组治疗后中医证候积分、明尼苏达心力衰竭生活质量量表（MLHFQ）评分，血清NT-proBNP、TnI、CK-MB、PRA、AngⅡ、醛固酮水平均较治疗前降低，6 min步行试验距离、左心室射血分数（LVEF）均较治疗前延长/增高（均P＜0.05）。观察组治疗后中医证候积分、MLHFQ评分，血清NT-proBNP、TnI、CK-MB、PRA、AngⅡ、醛固酮水平均低于对照组，6 min步行试验距离、LVEF均长于/高于对照组（均P＜0.05）。2组不良反应发生率比较差异无统计学意义（P＞0.05）。结论 生脉强心颗粒联合西药常规治疗能显著抑制RAAS系统，改善老年CHF患者心功能和生活质量。

• Objective To investigate the clinical efficacy of Shengmai Qiangxin granules in the treatment of senile chronic heart failure (CHF) and its regulatory effect on the renin-angiotensin-aldosterone system (RAAS). Methods A prospective randomized controlled trial was designed, and 94 elderly CHF patients with Qi-Yin deficiency complicated with blood stasis admitted to the Second Affiliated Hospital, Heilongjiang University of Chinese Medicine from January 2022 to January 2025 were enrolled. They were divided into the control group and the observation group with 47 cases in each group by the stratified block randomization method. The control group received conventional western medicine and Chinese medicine placebo treatment, while the observation group was given Shengmai Qiangxin granules on the basis of conventional western medicine treatment, with a course of 8 weeks. The curative effect, traditional Chinese medicine (TCM) syndrome score, 6 min walk test distance, quality of life, cardiac function indexes, N-terminal pro-brain natriuretic peptide (NT-proBNP), troponin I (TnI), creatine kinase isoenzyme MB (CK-MB) and RAAS indexes including plasma renin activity (PRA), angiotensin Ⅱ (AngⅡ) and aldosterone levels were compared between the two groups. The incidence of adverse reactions was also compared between the two groups. Results The total effective rate of the observation group after treatment was higher than that of the control group ［93.6%(44/47) vs 74.5%(35/47)］(P=0.011). After treatment, the TCM syndrome score, Minnesota living with heart failure questionnaire (MLHFQ) score, and serum levels of NT-proBNP, TnI, CK-MB, PRA, AngⅡ and aldosterone in both groups were lower than those before treatment, while the 6 min walk test distance and left ventricular ejection fraction (LVEF) were longer/higher than those before treatment (all P＜0.05). After treatment, the TCM syndrome score, MLHFQ score, and serum levels of NT-proBNP, TnI, CK-MB, PRA, AngⅡ and aldosterone in the observation group were lower than those in the control group, while the 6 min walk test distance and LVEF were longer/higher than those in the control group (all P＜0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P＞0.05). Conclusionshengmai Qiangxin granules combined with conventional western medicine treatment can significantly inhibit the RAAS, and improve cardiac function and quality of life in elderly patients with CHF.